Fondaparinux in Patients With Acute Heparin-Induced Thrombocytopenia (HIT)

Fondaparinux in Patients With Acute Heparin-Induced Thrombocytopenia

The purpose of this study is to test the safety and efficacy of fondaparinux in patients with heparin-induced thrombocytopenia (HIT). The primary objective is to ensure that patients with HIT who are treated with fondaparinux experience a prompt and complete recovery of their platelet count, and the secondary objective is to determine if any new blood clots are formed while receiving the fondaparinux and up to one month after study enrollment. This information will be compared to a historical control.

Study Overview

• Status: Withdrawn
• Conditions: Heparin-Induced Thrombocytopenia
• Intervention / Treatment: Drug: fondaparinux; Drug: argatroban or lepirudin

• Study Type: Interventional
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female at least 18 years of age;
• If female of childbearing potential, negative pregnancy test result;
• Diagnosis of HIT confirmed by the following: Decreased platelet count by 50% or greater OR platelets < 100,000/mm3 during or within 2 weeks after heparin exposure and/or new thromboembolic complications during or within 2 weeks after heparin exposure;
• Laboratory confirmation (either heparin PF4 antibody or serotonin release assay positive).

Exclusion Criteria:

• Estimated creatinine clearance less than 30 ml/min (either measured or by using Cockcroft Gault equation);
• Pregnancy or lactating;
• Blood dyscrasia other than HIT;
• History of thrombocytopenia associated with fondaparinux;
• Recent (within 6 weeks) or planned surgery of CNS, eye or traumatic surgery resulting in large open surfaces or other procedures with high bleeding risk or if lumbar puncture is planned;
• Active bleeding of GI tract, GU tract, CNS or respiratory tract;
• Malignant hypertension, pericarditis, pericardial effusion, endocarditis or eclampsia;
• Inadequate laboratory facilities, inadequate support system at home, alcoholism, drug abuse, psychosis or dementia;
• Hypersensitivity or contraindication to warfarin or fondaparinux.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: A; Fondaparinux	Drug: fondaparinux; fondaparinux subcutaneous injection once daily until INR stable in therapeutic range, at least five days: 5 mg if less than 50 kg, 7.5 mg if 50-100 kg, 10 mg if >100 kg; Other Names: Arixtra
ACTIVE_COMPARATOR: B; Direct thrombin inhibitor	Drug: argatroban or lepirudin; continuous infusion titrated into therapeutic range and for at least 5 days and until INR stable in therapeutic range; Other Names: Refludan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Platelet count recovery	5 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Recurrent thromboembolic complications	4 weeks

Collaborators and Investigators

• Sponsor: Methodist Healthcare
• Collaborators: University of Tennessee
• Investigators: Principal Investigator: Bob L Lobo, Pharm.D., Methodist University Hospital; Principal Investigator: Sohail Minhas, MD, University of Tennessee

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (ACTUAL): July 1, 2009
• Study Completion (ACTUAL): July 1, 2010

Study Registration Dates

• First Submitted: January 4, 2008
• First Submitted That Met QC Criteria: January 16, 2008
• First Posted (ESTIMATE): January 29, 2008

Study Record Updates

• Last Update Posted (ACTUAL): August 13, 2019
• Last Update Submitted That Met QC Criteria: August 12, 2019
• Last Verified: June 1, 2009

More Information

Terms related to this study

• Keywords: fondaparinux; heparin-Induced thrombocytopenia
• Additional Relevant MeSH Terms: Hematologic Diseases; Blood Platelet Disorders; Thrombocytopenia; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Fondaparinux; PENTA; Argatroban; Lepirudin
• Other Study ID Numbers: MHIRB # 2007-058